Document Detail


Effect of a short course of rhDNase on cough and mucociliary clearance in patients with cystic fibrosis.
MedLine Citation:
PMID:  10862158     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The aim of the study was to measure the effect of a short course of recombinant human deoxyribonuclease I (rhDNase) on ciliary and cough clearance in a group of cystic fibrosis patients, using a radioaerosol and gamma camera technique. Patients were initially randomized to receive either rhDNase (2.5 mg qd) or placebo. Following the measurement of baseline clearance, patients were given a 7-day course of either rhDNase or placebo. The patient then returned on the seventh day for follow-up clearance measurements. This was followed by a 2-week washout period before the whole process was repeated with the alternative inhalation solution. On each of the study days, mucociliary clearance was initially measured for a period of 60 min (IC). This was followed by cough clearance (CC) measurements for 30 min, during which patients were requested to cough a total of 120 times. Post-cough clearance (PCC) was then measured for a further 60 min. Thirteen patients completed the study. Patients' age ranged between 18-38 years, and they had baseline values of FEV(1) of 27-103% of predicted values. Following completion of the course of rhDNase, there was a mean percent increase from baseline of 7.5% for FEV(1) and 5.4% for FVC% (P = 0. 03). There was a small, nonsignificant increase in IC (6.2 +/- 3.6%) on the rhDNase arm compared with the placebo arm (-2.3 +/- 2.9%), P = 0.1. No changes were seen in either CC (1.0 +/- 3.2% [rhDNase] vs. 1.9 +/- 2.4% [placebo], P = 0.9) or PCC (-0.7 +/- 1.5% [rhDNase] vs. 0.9 +/- 1.7% [placebo], P = 0.3). Patients who achieved a 10% or greater improvement in FEV(1) (n = 5) in response to rhDNase did not show any greater change in clearance than nonresponders. In conclusion, we were unable to demonstrate any improvements in either ciliary or cough clearance in response to a short course of rhDNase. The mechanism of action of this drug in vivo remains uncertain.
Authors:
M Robinson; A L Hemming; C Moriarty; S Eberl; P T Bye
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatric pulmonology     Volume:  30     ISSN:  8755-6863     ISO Abbreviation:  Pediatr. Pulmonol.     Publication Date:  2000 Jul 
Date Detail:
Created Date:  2000-08-03     Completed Date:  2000-08-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8510590     Medline TA:  Pediatr Pulmonol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  16-24     Citation Subset:  IM    
Copyright Information:
Copyright 2000 Wiley-Liss, Inc.
Affiliation:
Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, Australia. mr@mail.med.usyd.edu.au
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Adolescent
Adult
Aerosols
Cough / drug therapy*,  metabolism,  physiopathology,  radionuclide imaging
Cross-Over Studies
Cystic Fibrosis / drug therapy*,  metabolism,  physiopathology,  radionuclide imaging
Deoxyribonuclease I / administration & dosage,  therapeutic use*
Double-Blind Method
Expectorants / administration & dosage,  therapeutic use*
Female
Humans
Male
Mucociliary Clearance / drug effects*
Recombinant Proteins / administration & dosage,  therapeutic use
Respiratory Function Tests
Treatment Outcome
Chemical
Reg. No./Substance:
0/Aerosols; 0/Expectorants; 0/Recombinant Proteins; EC 3.1.21.1/DNASE1 protein, human; EC 3.1.21.1/Deoxyribonuclease I

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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